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FDA approves Janssen’s Yondelis

Provides additional treatment option for softtissue sarcoma
FDA

Janssen's Yondelis has been approved by the FDA for the treatment of unresectable or metastic liposarcoma or leiomyosarcoma.

The US approval comes on the back of data from a phase III trial which evaluated Yondelis (trabectedin) versus dacarbazine.

The study involved 518 patients with previously treated liposarcoma (LPS) or leiomyosarcoma (LMS) with results showing similar median overall survival of around 12 months.

However, Yondelis showed a significant improvement in progression-free survival of 4.2 months versus dacarbazine's 1.5 months.

Luis Mora, managing director of Janssen's licensing partner PharmaMar, said: “Since Yondelis was first approved in Europe in 2007 approximately 50,000 patients in 80 countries have benefited from this therapy across all indications.

“The approval in the US will allow more patients with this disease to have access to a drug that will address an unmet medical need.”

Yondelis received fast-track approval from the FDA in February this year and is now approved in 80 countries for a variety of indications.

LPS and LMS account for 35% of all soft tissue sarcoma cases of which there are 50 subtypes. LMS is aggressive and generally occurs in smooth muscles such as those in the uterus, abdominal cavity or blood vessels.

LPS originates in fat cells and most commonly occurs in the thigh and abdominal cavity though it can occur in fat cells anywhere in the body.

Currently over 12,000 people in the US are diagnosed with STS and approximately 4,7000 die as a result of the disease. 

Article by
Nikhil Patel

29th October 2015

From: Regulatory

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